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44 Plasma KCE Reports 120 • Idiopathic thrombocytopenic purpura: in children and in adults presenting a high risk of bleeding or for those awaiting surgery 2. Neurological indications • Guillain-Barré syndrome, with specific criteria • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), with specific criteria • Multifocal motor neuropathy (MMN), with specific criteria 3. Other indications • Kawasaki disease • Treatment of the toxic shock syndrome (TSS) due to streptococcal infections Table 19: Indications and reimbursement by pharmaceutical specialty of intravenous immunoglobulins, Belgium, as of October 2008 Indications / brand product Sandoglobulin Multigam® Gammagard® of immunoglobulin ® a Octagam® Nanogam® Primary immune deficiency conditions (specified) I, R I, R I, R I, R Multiple myeloma and chronic lymphocytic leukaemia I, R I, R I, R I, R Paediatric AIDS R I, R I, R I, R Idiopathic thrombocytopenic purpura I, R I, R I, R I, R Guillain-Barré syndrome I, R I, R I, R I, R Kawasaki disease R I, R R I, R Allogenous bone marrow transplant I, R I, R I, R I, R Treatment of septicaemia in preterm and neonates R I, R (2002) Treatment of toxic shock syndrome due to streptococcal infection I, R Chronic inflammatory demyelinating polyradiculoneuropathy I, R (2002) I, R (2003) Multifocal motor neuropathy I, R (2002) R (2008) Rheumatoid polyarthritis I For humoral immune deficiency I (R for above I (R for above following cytostatic treatment indications) indications) I: included in indications R: reimbursed indication (date of introduction of reimbursement) a: interpretation of the indications that are labelled in these general terms: “used in the substitution treatment of primary and secondary immune deficiencies, as for the prevention of infections resulting from these immune deficiencies. Used in the aim of modifying or controlling the immune response in many diseases.” The list of reimbursed indications per brand product has also evolved over time. The neurological indications CIDP and MMN have been added in the list of reimbursed indications in July 2002 for Sandoglobulin® and later for Multigam® (CIDP in 2004 and MMN in 2008). For each patient with CIDP or MMN, there is a maximum reimbursement of 9 g/kg per patient every 6 months, after a positive clinical evaluation.
KCE Reports 120 Plasma 45 Subcutaneous immunoglobulins Sub-cutaneous immunoglobulins, Subcuvia® and Vivaglobin®, are reimbursed for the following indications: • Primary immune deficiency conditions: agammaglobulinemia, hypogammaglobulinemia with specific criteria, congenital deficiency in antipolysaccharidic antibodies with specific criteria • Multiple myeloma and chronic lymphocytic leukaemia. 3.2.1.2 Recommendations in other countries The recommendations for IG use in terms of which clinical indications can be treated with IG are presented for five other industrialized countries and compared to Belgium in Table 20. In Canada, the UK and Australia, guidelines are clearly stating that “IG therapy is not indicated” for specific conditions, described as “No” in the table, when applicable. The sources of these recommendations on IG use are described below: 1. In Canada, detailed national guidelines covering the haematological and neurological indications have been published in four articles in the journal Transfusion Medicine Reviews in 2007. 18-21 They have been elaborated by a special committee, based on scientific evidence and using expert panels. 2. In the United Kingdom, evidence-based guidelines from the Department of Health have been elaborated and the most updated version is dated May 2008. 17 Besides a list of recommendations on IG use, a list of “grey indications” has been established: grey indications are those “for which the evidence base is weak, in many cases because the disease is rare, and for which IVIG treatment should be considered on a case by case basis, prioritised against other competing demands”. This comprehensive list of grey indications is not included in the table unless the disease was listed in other country recommendations, and grey indications are indicated with a “(3)”, see Table 3 legend. This guideline also includes a short list of indications for which IVIG is not recommended (indicated as “No” in the table). 3. In the Netherlands, labelled indications are described in a document for prescribers from the Medicines Evaluation Board (2003). e 4. In France, full recommendations have not been yet established at national level. Each IG specialty has a limited list of authorized indications; in addition, a wider list of diseases for which IG is recommended has been published by the “Commission de la Transparence”, “Haute Autorité de Santé” (HAS) for specific products, and from the Drug Agency (AFSSAPS) for IG in general in its document «Proposition de hiérarchisation des indications des immunoglobulines humaines intraveineuses (IgIV) en situation de tension forte sur les approvisionnements pour le marché français, 06/05/2008 ».f Clinical indications have been categorized per level of priority in several groups, to identify patients that should receive IG in a context of shortage. On one hand, the indications included in the marketing authorizations (Autorisation de Mise sur le Marché or AMM) have been classified in priority groups: priority indications; indications to keep for vital emergencies or after failure of alternative treatment; and non-priority indications (that can wait till shortage end). On the other hand, a list of diseases non included in the AMM e Medicines Evaluation Board. http://db.cbg-meb.nl/IB-teksten/h16942.pdf f AFSSAPS. Proposition de Hiérarchisation des indications des IgIV reconnues dans l'AMM, disponible dans la circulaire DGS/PP/DHOS/E2/AFSSaPS/2008/92 du 14/03/2008 relative à la surveillance des approvisionnements en immunoglobulines humaines normales et à la gestion des situations de tension. 6 June 2008. Available on http://www.afssaps.fr/Infos-de-securite/Autres-mesures-de-securite/Propositionde-hierarchisation-des-indications-des-immunoglobulines-humaines-intraveineuses-IgIV-en-situation-detension-forte-sur-les-approvisionnements-pour-le-marche-francais2 Accessed January 2009.
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Comment assurer l’autosuffisance
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Comment assurer l’autosuffisance
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KCE Reports 120 Plasma 121 APPENDIX
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KCE Reports 120 Plasma 125 Table 48
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